Job Details  
Advertiser: Quanta Consultancy Services Limited

Job Title: Associate Director Regulatory Affairs, Strategy
Rate:£70K to £75K Per Year
Description: Are you looking for a step up into an Associate Director position within Regulatory Affairs? Do you have experience in Regulatory strategy for the European or Japanese and Chinese market? This could be the role for you!

A global pharmaceutical company in Cambridge are actively hiring for an Associate Director of Regulatory Affairs Strategy to join their team. This will be to develop and lead regulatory strategies and initial registration plans for development and approval of specific products.

Responsibilities include:

- Serve as the Regulatory Affairs lead representative on the product development Asset Team
- Provide regulatory expertise on current drug development and marketing authorisations requirements and procedures to develop faster to market product development and approval strategies with optimal labelling.
- Lead the development of the Strategic Regulatory Plan for the assigned project(s) including assessment of the probability of regulatory success together with risk mitigation measures and deliver regulatory milestones in accordance with the Plan
- Ensure the delivery of high quality submissions (CTA/IND, MAA/NDA, orphan drug designation, scientific advice applications) in a timely manner
- Initiate and manage appropriate responses to agency review issues, ensuring efficient review and approval of submissions within assigned timelines

The candidate must have at least 2 years managerial experience and 10+ years` experience in the... Please go to to see the full advert text.
Skills Required: Associate Director Regulatory Affairs, Strategy
Job Type: Permanent
Start Date: 02-02-2018
Contact: Nicolle Kniebe Contact E-mail: Click
Contact Tel: (0) 1442 860 521 Contact Fax:
Reference: 20109 Added: 02-02-2018
  IMPORTANT: For jobs based in the UK it is unlawful to employ a person who does not have permission to live and work in the UK. Please ensure you have this permission before applying, unless the advert states otherwise.
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